07/22/2021

VGM Sends Letter To FDA Asking To Expedite The Approval Of The Philips Respironics Alternative Sound Abatement Foam

The following message was released by VGM Government Relations on 7/21/22:

VGM recognizes the impact that the current shortage of CPAP/RAD machines is having on your business and the DME industry as a whole. Until Philips Respironics receives approval from the FDA (Food and Drug Administration) regarding:

1) the process that will be used to repair and replace devices impacted by the recall and

2) the use of an alternative sound abatement foam in their devices,

they cannot offer any new or replacement units for those impacted by the recall. In an effort to expedite the FDA’s approval process for the alternative foam, VGM has sent this letter to the FDA outlining the implications of the recall and subsequent product shortage.

If you would like to reach out to the FDA with concerns regarding the Phillips Respironics recall, you may do so utilizing the FDA’s reporting portal - https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home. You may also contact the Division of Industry and Consumer Education at dice@fda.hhs.gov. You can also submit a letter directly to your FDA recall Coordinators based on your state. Visit this link for information: https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators